Successful first “Aeson® European User Meeting”, marking an important step in the deployment of CARMAT’s artificial heart

• CARMAT has responded to all remaining questions from the conditional approval
• Number of subjects to be enrolled in the study extended to 10 patients

Paris, February 5, 2020 – 5:45 pm CET

CARMAT (FR0010907956, ALCAR), the designer and developer of the world’s most advanced total artificial heart, aiming to provide a therapeutic alternative for people suffering from end-stage biventricular heart failure, announces that the US Food and Drug Administration (FDA) has fully approved the Company’s Investigational Device Exemption (IDE) application to start a US Early Feasibility Study (EFS) of its total artificial heart.

The amended EFS protocol includes 10 transplant-eligible subjects limited to a network of 7 US renowned institutions. The primary endpoint of the study is patient survival at 180 days post-implant or a successful cardiac transplantation within 180 days post-implant. It is a staged study with a progress report of the first 3 patients after 60 days, before the enrollment of the next 7 patients.

CARMAT also obtained conditional approval from two Institutional Review Boards (IRB) and this full FDA approval enables the company to accelerate the discussions with the other IRB and research contract offices at the 7 sites. The company is also working closely with the Centers for Medicare & Medicaid Services (CMS) to obtain a coverage of the costs of the trial, with the objective to start patient enrolment in Q4 2020.

CARMAT will present the EFS protocol at the 2020 symposium on mechanical support for the heart and lung of the American Association for Thoracic Surgery (AATS) on February 14, 2020, in Houston (Texas).

Stéphane Piat, Chief Executive Officer of CARMAT, said: “The full approval to initiate a US study marks another milestone for CARMAT and confirms the trust of the FDA in our ability to conduct the feasibility study of the first bioprosthetic artificial heart in the United States. Considering the ongoing approval procedures with the Institutional Review Boards at the selected centers and discussions on the potential reimbursement of the treatment costs, we expect patient enrolment to start in Q4 2020.”

Paris, January 7, 2020 – 5:45 pm CET

CARMAT (FR0010907956, ALCAR), the designer and developer of the world’s most advanced artificial heart project, aiming to provide a therapeutic alternative for people suffering from end-stage biventricular heart failure, today announces its indicative financial calendar for 2020.

This preliminary agenda may be modified. Each publication will be released before market opening.

Paris, December 9, 2019 – 7.00 am CET

CARMAT (FR0010907956, ALCAR), the designer and developer of the world’s most advanced total artificial heart project, aiming to provide a therapeutic alternative for people suffering from end-stage biventricular heart failure, today announced that a 12th patient of the PIVOTAL study has been implanted in the Czech Republic.

This implant was performed by the team headed by Prof. Ivan Netuka, Chair of the Department of Cardiovascular Surgery at the Institute of Clinical and Experimental Medicine (IKEM) in Prague and Principal Investigator of the second part of the PIVOTAL study.

Stéphane Piat, Chief Executive Officer of CARMAT, said: “We are very pleased to announce the resumption of implants in Prague. The surgical procedure was performed satisfactorily a few days ago, and the patient is continuing his gradual recovery. We noticed, both at the Prague center and in Nur-Sultan, an increased flow of eligible patients, which should enable the medical teams to enroll patients at a faster pace than for the first cohort, in line with our aim of obtaining CE marking in 2020.”

• The Company has received the approval of the Kazakhstan health authority and the ethics committee of the National Research Center for Cardiac Surgery in Nur-Sultan, which has substantial experience with the CARMAT device
• The study can now be conducted simultaneously in 3 countries

Paris, December 2, 2019 – 7.00 am CET

CARMAT (FR0010907956, ALCAR), the designer and developer of the world’s most advanced total artificial heart project, aiming to provide a therapeutic alternative for people suffering from end-stage biventricular heart failure, today announced that it has received authorization to resume the PIVOTAL study in Kazakhstan.

The implants will be performed at the National Research Center for Cardiac Surgery in Nur-Sultan (formerly called Astana), where the teams, led by Professor Yuri Pya, have successfully implanted the CARMAT device during the first part of the PIVOTAL study. Furthermore, several bridge-to-transplant surgeries conducted in this center demonstrated the ability of its surgical teams to successfully manage the explant procedure of the device as a donor heart becomes available. With authorizations in Kazakhstan, the Czech Republic and Denmark, the Company aims to complete enrollment of the second cohort of patients in the PIVOTAL study in order to obtain CE marking in 2020.

Stéphane Piat, Chief Executive Officer of CARMAT, said: “We are pleased to announce that we have been given the approval to enroll new patients in Kazakhstan. Together with the teams in Nur-Sultan, we are actively preparing for upcoming implants. With this approval, we reach our objective to resume the study at a center experienced both with device implantation and explant for transplant-eligible patients.”

Paris, November 27, 2019 – 07.00 am CET

CARMAT (FR0010907956, ALCAR), the designer and developer of the world’s most advanced total artificial heart project, aiming to provide a therapeutic alternative for people suffering from end-stage biventricular heart failure, today announced the appointment of Mr Alexandre Eleonore as Director
of Manufacturing.

Alexandre Eleonore is a confirmed industry expert with a strong background in operational management. He graduated from the Sevenans Polytechnic Institute, now UTBM (Université de Technologie Belfort-Montbéliard), and spent the first part of his career in leading automotive equipment manufacturers such as Faurecia and Plastic Omnium. After 10 years in this sector, he joined the Sorin group in 2009, which became Microport CRM, one of the world’s leading players in the treatment of cardiac rhythm disorders. He became Vice President Operations & Customer Service and implemented cost improvement plans, thanks to his knowledge of lean manufacturing and industrial process automation.

“Joining CARMAT and its teams is obvious to me. Following the excellent work done with the first prostheses, it is now a matter of preparing the large-scale production of one of the most complex medical devices ever invented. It is both a technical and a human challenge to establish the right industrial processes that will enable us to meet market demand,” said Alexandre Eleonore, Director of Manufacturing of CARMAT.

Stéphane Piat, Chief Executive Officer of CARMAT, commented: “We are very pleased to welcome Alexandre Eleonore to our management team. As Director of Manufacturing, his role will be to develop the processes related to the ramp-up of the Bois-d’Arcy site, while working on reducing the production costs of the prosthesis, in line with the continued transformation of CARMAT into an industrial and commercial company. His dual expertise in major industrial sectors such as automotive and health will be a key advantage for the commercial phase, which will require the production of several hundred prostheses per year with a high level of quality.”

• The Company has received the approval of the Czech health authority and the ethics committee of the IKEM center in Prague, which has substantial experience with the CARMAT device
• CARMAT is in advanced talks to also resume the study in Kazakhstan

Paris, November 19, 2019 – 5.45 pm CET

CARMAT (FR0010907956, ALCAR), the designer and developer of the world’s most advanced total artificial heart project, aiming to provide a therapeutic alternative for people suffering from end-stage biventricular heart failure, today announced that it has received authorization to resume the PIVOTAL study in the Czech Republic.

The implants will be performed at the Institute of Clinical and Experimental Medicine (IKEM) in Prague, whose teams have benefited from a major learning curve acquired through implanting the CARMAT device during the first part of the PIVOTAL study. The screening for the second patient cohort, who will receive the new prostheses produced at the Bois-d’Arcy site, is already underway. The Company is also in advanced talks with the Kazakhstani health authorities regarding the resumption of the study at the National Research Center for Cardiac Surgery in Nur-Sultan (formerly called Astana). With authorizations in these strategic countries, given the experience they have acquired to date with the CARMAT artificial heart, and Denmark, the Company is aiming to intensify enrollment in the PIVOTAL study in order to finalize it as soon as possible and obtain CE marking in 2020.

Stéphane Piat, Chief Executive Officer of CARMAT, said: “We are pleased to announce that we have been given approval to enroll new patients in the Czech Republic. In close collaboration with the teams of the IKEM cardiac center in Prague, we are already preparing for upcoming implants. This approval was eagerly expected, as our will was to resume the study at an experienced center before including other facilities. Following this key authorization for our project, we also expect a rapid resumption in Kazakhstan.”

Paris, November 14, 2019 – 6.00 pm CET

CARMAT (FR0010907956, ALCAR), the designer and developer of the world’s most advanced total artificial heart project, aiming to provide a therapeutic alternative for people suffering from end-stage biventricular heart failure, today announced its participation in the Jefferies Healthcare Conference to be held on November 20-21, 2019 in London.

Stéphane Piat, Chief Executive Officer of CARMAT, will participate in investors meetings and present the company during a plenary session on Wednesday, November 20, at 5.20 pm (London time).

The presentation of CARMAT will be accessible live via the link:

http://wsw.com/webcast/jeff123/alcar.pa/

• 73% of patients achieved the primary endpoint of the study
• Considerable strengthening of the prosthesis’ 6-month safety profile, with no adverse events in the latest patients
• To date, the prosthesis has achieved a record duration of over 20 months of individual support

Paris, November 6, 2019 – 7.00 am CET

CARMAT (FR0010907956, ALCAR), the designer and developer of the world’s most advanced total artificial heart project, aiming to provide a therapeutic alternative for people suffering from end-stage biventricular heart failure, today published an update on the progress of its clinical experience within the framework of the PIVOTAL study.

Stéphane Piat, Chief Executive Officer of CARMAT, said: “As we prepare to resume the PIVOTAL study in the coming weeks, I am delighted to observe that the results recorded with the first 11 patients, very encouraging, continue to strengthen the future positioning of CARMAT as a credible and efficient therapy to provide a response to the issue of biventricular heart failure. Indeed, it is extremely rare to generate such conclusive results as quickly as this in clinical research. In addition to achieving a high 6-month survival rate, we have also significantly reduced perioperative bleeding in the last three patients, while avoiding the risk of cerebrovascular accidents, gastrointestinal bleeding or infections associated with the percutaneous power cable. These compelling results should enable us to rapidly obtain the necessary authorizations in the Czech Republic and Kazakhstan, where we intend to resume the study by capitalizing on the level of experience they have acquired during the first part of the study”.

The primary endpoint of the study, corresponding to 6-month survival with the bioprosthesis or a successful transplant within 6 months after device implant, was achieved in 73% of the first 11 patients enrolled in the PIVOTAL study. By comparison, this rate was just 50% during the feasibility study (4 patients), and is 54-62% for the only total artificial heart currently on the market[1] and 46%-68% for mechanical biventricular circulatory support systems[2].

The analyses of the secondary objectives of the PIVOTAL study also help establish excellent 6-month safety profile of the prosthesis. Indeed, no adverse effects related to the device, such as a cerebrovascular accident, gastrointestinal bleeding or infections associated with the percutaneous power cable, have been observed. Perioperative bleeding was observed in just 36% of patients, a lower rate than that of the only total artificial heart currently on the market (41%)[3]. Furthermore, applying the new protocol has helped totally eliminate perioperative bleeding in the last three patients.

The device has also proven its ability to respond to variations in the patient’s physical efforts by automatically modifying the flow, confirming that the self regulation system works correctly.

Moreover, excellent results have been observed in patients eligible for a heart transplant: following between 3 and 10 months of support with the CARMAT artificial heart, 5 patients have received a new heart following a successful explantation procedure.

Patients in the study who are continuing to benefit from the support of the bioprosthesis have seen their quality of life improve thanks to the portable system that has enabled them to swiftly return home and regain their mobility.

To date, the maximum duration of individual support is over 20 months, which is particularly encouraging for the second part of the study given the technical enhancements made to the new generation of prostheses manufactured at the Bois-d’Arcy plant.

[1] Kirklin JK et al, J Heart Lung Transplant 2018;37:685-691. Arabia F et al, J Heart Lung Transplant, 2018;37:1304–1312

[2] Lavee J et al, J Heart Lung Transplant 2018;37:1399−1402. Arabia F et al, Ann Thorac Surg 2018;105:548–56

[3] Kirklin JK et al., JHLT 2018;37:685-691. Arabia F et al., JHLT, 2018;37:1304–1312.  Demondion P et al., EJCS. 2013 Nov;44(5):843-8